FDA Device recall Z-2968-2026
Blanketrol II Model 222S
- FDA Device
- Class II
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class II recall of Blanketrol II Model 222S by Gentherm Medical, citing overheating of the 115V CPU board may cause the device to shut down.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2968-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-13 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Gentherm Medical |
| Distribution | US |
Product
Blanketrol II Model 222S; Thermal regulating system.
Reason
Overheating of the 115V CPU board may cause the device to shut down.
Identifiers
| code_info | UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2968-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.